Does Oxytocin Alter Tolerance to or Motivation for Alcohol
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Alcohol Use Disorder
In brief
This pilot study is intended to demonstrate feasibility and acquire preliminary data. If successful, this data could support a future project studying the effect of oxytocin on tolerance and alcohol seeking in humans.
Key facts
- Study ID
- NCT05312008
- Run by
- Indiana University
- People needed
- 6
- Starts
- 2022-01-16
- Expected to finish
- 2023-12-21
- Last updated by the study team
- 2025-03-04
Who can join
Age: 21 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Heavy alcohol drinkers.
- Able to understand/complete questionnaires and procedures in English.
- Have venous access sufficient to allow blood sampling.
You may not qualify if…
- Latex allergy.
- Nasal condition that compromises delivery and/or absorption of intra-nasal oxytocin
- Pregnant or breast-feeding women.
- Desire to be treated for any substance use disorder or court ordered to not drink alcohol
- Medical disorders or other conditions such as alcohol withdrawal seizures or delirium tremens that may influence study outcome or participant safety.
- Positive urine drug screen for amphetamines/ methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, or phencyclidine if determined by the PI to adversely affect participant safety or data integrity.
- Medications (past 30 days) that could influence participant safety or data integrity (e.g. antidepressants, antipsychotics, benzodiazepines, etc.) as determined by the PI.
- DSM 5 Disorders (other than alcohol) or current/history of neurological disease of cerebral origin, or head injury with > 20 min loss of consciousness, if determined by the PI to affect participant safety or data integrity.
- Positive breath alcohol reading at beginning of the experimental session.
- Actively suicidal (for example, any current suicidal intent, including a plan) or are at serious suicidal risk, by clinical judgment of the PI.
- Any condition for which the PI and investigative team determine it is unsafe or not prudent to enroll a participant.
Where it is running
- University Hospital — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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